Comparative study of the number of report and time‐to‐onset of the reported adverse event between the biosimilars and the originator of filgrastim

Kobayashi, Tetsu; Kamada, Izumi; Komura, Junko; Toyoshima, Satoshi; Ishii‐Watabe, Akiko

doi:10.1002/pds.4218

Cited by 5 publications

(3 citation statements)

References 25 publications

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“…Use of phenol as a stabilizer in multidose vial formulations may have contributed, because no anaphylaxis cases were observed with a single‐dose peginesatide formulation that did not include the phenol stabilizer . The World Health Organization's pharmacovigilance database includes more than 100 spontaneously reported adverse event reports for three biosimilar filgrastims marketed in EU countries, but no report for any person receiving biosimilar filgrastim in Japan, Canada, or the U.S. . If a substitution from reference filgrastim to a biosimilar filgrastim occurs and is a suspected cause of an adverse event, the event cannot be evaluated unless product‐specific information is available.…”

Section: Pharmacovigilancementioning

confidence: 99%

Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada

et al. 2019

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Biosimilar filgrastims are primarily indicated for chemotherapy-induced neutropenia prevention. They are less expensive formulations of branded filgrastim, and biosimilar filgrastim was the first biosimilar oncology drug administered in European Union (EU) countries, Japan, and the U.S. Fourteen biosimilar filgrastims have been marketed in EU countries, Japan, the U.S., and Canada since 2008, 2012, 2015, and 2016, respectively. We reviewed experiences and policies for biosimilar filgrastim markets in EU countries and Japan, where uptake has been rapid, and in the U.S. and Canada, where experience is rapidly emerging. U.S. regulations for designating biosimilar interchangeability are under development, and such regulations have not been developed in most other countries. Pharmaceutical substitution is allowed for new filgrastim starts in some EU countries and in Canada, but not Japan and the U.S. In EU countries, biosimilar adoption is facilitated with favorable hospital tender offers. U.S. adoption is reportedly 24%, while the second filgrastim biosimilar is priced 30% lower than branded filgrastim and 20% lower than the first biosimilar filgrastim approved by the U.S. Food and Drug Administration. Utilization is about 60% in EU countries, where biosimilar filgrastim is marketed at a 30%-40% discount. In Japan, biosimilar filgrastim utilization is 45%, primarily because of 35% discounts negotiated by Central Insurance and hospital-only markets. Overall, biosimilar filgrastim adoption barriers are small in many EU countries and Japan and are diminishing in Canada in the U.S. Policies facilitating improved U.S. adoption of biosimilar filgrastim, based on positive experiences in EU countries and Japan, including favorable insurance coverage; larger price discount relative to reference filgrastim pricing; closing of the "rebate trap" with transparent pricing information; formal educational efforts of patients, physicians, caregivers, and providers; and allowance of pharmaceutical substitution of biosimilar versus reference filgrastim, should be considered. The Oncologist 2019;24:537-548 Implications for Practice: We reviewed experiences and policies for biosimilar filgrastims in Europe, Japan, Canada, and the U.S. Postmarketing harmonization of regulatory policies for biosimilar filgrastims has not occurred. Acceptance of biosimilar filgrastims for branded filgrastim, increasing in the U.S. and in Canada, is commonplace in Japan and Europe. In the U.S., some factors, accepted in Europe or Japan, could improve uptake, including acceptance of biosimilars as safe andThe Oncologist 2019;24:537-548 www.TheOncologist.com New Drug Development and Clinical Pharmacology effective; larger cost savings, decreasing "rebate traps" where pharmaceutical benefit managers support branded filgrastim, decreased use of patent litigation/challenges, and allowing pharmacists to routinely substitute biosimilar for branded filgrastim.

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Section: Pharmacovigilancementioning

confidence: 99%

Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada

et al. 2019

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“…Internal formula validation in our centre evidenced several benefits. Despite the fact that using the formula resulted in an increase of TBVs processed in most groups of patients, as a consequence, it was possible to reduce the number of aphereses in individuals younger than 60 years; this led to a lower use of G-CSF and plerixafor with the consequent lower exposure to adverse effects of these drugs [17][18][19][20][21].…”

Section: Discussionmentioning

confidence: 99%

Prediction of blood volume to be processed to achieve a target number of CD34+ cells: Development, validation and implementation of a formula

et al. 2023

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Background and Objectives Calculation of blood volume (BV) to be processed to achieve the target number of CD34+ cells can be accomplished by using collection efficiency 2 (CE2) formula. Our aim was to develop a BV web formula. Materials and Methods We calculated CE2 from aphereses performed between January 2015 and March 2020 in allogeneic donors and patients. From May 2020 to May 2021, we validated a formula: BV = ((Target CD34+ cells in the product)/(CD34+ pre‐apheresis cells × CE2)) × 100. Subsequently, we compared the outcome of the procedures carried out before formula implementation (pre‐formula), when standard three total BV collection was performed. Results CE2 was assessed in 384 apheresis procedures before formula implementation. CE2 was higher in allogeneic donors than in patients (53% ± 17% vs. 48% ± 15%, p = 0.008). CE2 was higher in multiple myeloma and non‐Hodgkin lymphoma than Hodgkin's lymphoma (48% ± 15%, 48% ± 15% and 42% ± 13%, respectively; p = 0.008). Our formula (available on a website: Publisheet) was prospectively used in 54 individuals. The formula was very accurate: predicted versus observed CD34 + cells/kg collected had an r‐value of 0.89 (p < 0.0001). We compared their results with 78 pre‐formula individuals. In the post‐formula group, a greater BV was processed in patients and less BV in allogeneic donors. Among individuals under 60 years of age, it was significantly less frequent than the need for more than one apheresis in the post‐formula group. Conclusion Formula calculations were accurate. Formula implementation allowed the optimization of the procedures and reduced the rate of individuals in need of apheresis for more than 1 day.

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“…7 Further, the evidence generated through postmarketing comparative utilization and safety studies of biosimilars and reference biologics may help ensure the safety and effectiveness of a biosimilar and instill health care provider and patient confidence in these products. 8,9 The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) is a nonprofit public service initiative dedicated to providing scientific evidence on the comparative safety and effectiveness of biosimilars and reference biologics, with participants from managed care organizations, integrated delivery systems, pharmacy benefit management firms, research institutions, and pharmaceutical companies. 10,11 The BBCIC's Distributed Research Network (DRN) consists of geographically diverse U.S. commercial, including Medicare Advantage, health plans that also participate in the FDA Sentinel System, thus enabling BBCIC to conduct claims-based research specific to biologics using the Sentinel common data model and analytic tools.…”

Section: Medication Exposure and Covariatesmentioning

confidence: 99%

Incidence of Serious Infections and Design of Utilization and Safety Studies for Biologic and Biosimilar Surveillance

Zhang

Sridhar

Barr

et al. 2020

JMCP

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BACKGROUND: There is a need for postmarketing evidence generation for novel biologics and biosimilars. OBJECTIVE: To assess the feasibility, strengths, and limitations of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Distributed Research Network (DRN) to examine the utilization and comparative safety of immune-modulating agents among patients with autoimmune diseases. METHODS: We conducted a retrospective cohort study among patients enrolled in health insurance plans participating in the BBCIC DRN between January 1, 2006, and September 30, 2015. Eligible patients were adult (≥18 years) new users of a disease-modifying nonbiologic and/or biologic agent with a prior diagnosis of rheumatoid arthritis (RA), other inflammatory conditions (psoriasis, psoriatic arthritis, ankylosing spondylitis), or inflammatory bowel disease (IBD). Follow-up started at treatment initiation and ended at the earliest of outcome occurrence (serious infection); treatment discontinuation; or switching, death, disenrollment, or end of study period. The study leveraged the FDA Sentinel System infrastructure for data management and analysis; descriptive statistics of patient characteristics and unadjusted incidence rates of study outcomes during follow-up were calculated. RESULTS: Eligible patient drug episodes included 111,611 with RA (75% female), 61,050 with other inflammatory conditions (51% female), and 30,628 with IBD (52% female). Across all 3 cohorts, approximately half of the patient drug episodes initiated a biologic (50% in RA; 60% in psoriasis, psoriatic arthritis, ankylosing spondylitis; and 55% in IBD). The crude incidence rate of serious infection was 9.8 (9.5-10.0) cases per 100 personyears in RA, 7.1 (6.8-7.5) in other inflammatory conditions, and 14.2 (13.6-14.8) in IBD patients. CONCLUSIONS: This study successfully identified large numbers of new users of biologics and produced results that were consistent with those from earlier published studies. The BBCIC DRN is a potential resource for surveillance of biologics.

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Comparative study of the number of report and time‐to‐onset of the reported adverse event between the biosimilars and the originator of filgrastim

Abstract: The difference in the TTO was identified between originator filgrastim Neupogen and its biosimilar regarding some PTs, which may suggest the difference in their safety profile. Copyright © 2017 John Wiley & Sons, Ltd.

Cited by 5 publications

References 25 publications

Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada

Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada

Prediction of blood volume to be processed to achieve a target number of CD34+ cells: Development, validation and implementation of a formula

Incidence of Serious Infections and Design of Utilization and Safety Studies for Biologic and Biosimilar Surveillance

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